Older Cancer PatientsNCT02174055
Identifying and Measuring Depression in Older Cancer Patients
An observational study of Older Cancer Patients, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to develop an accurate and useful way of measuring older patients' moods and reactions to the combined issue of cancer treatment and aging. Also, the purpose of this study is to test a new self-report measure of depressive symptoms tailored to the needs of older adults with cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Older Cancer Patients
- What is being tested?
- Patient Interviews, newly developed questionnaire and Pilot Testing the Draft Measure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 329 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2014to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: For all Phases, patients who are identified as eligible will be approached in-person in the outpatient clinics or the MSK Counseling Center by members of the research staff, or by letter (physical or electronic).
Who may be able to join
- For Patients in Phases 1- 3:
- Current or previous cancer diagnosis and treatment (any site and any stage)
- All Phases 1,2,3- 70 years of age or older
- For Phase 1b only; 50 participants ages 50-69 will also be recruited
- For Phase 2 only: As per medical record or self report, history of Depression, Dysthymia, or Adjustment Disorder with Depressed Mood
- For Phase 3 depressive subset: As per medical record or self report, a history of depressive symptoms such as
Show all 11Show fewer
- Adjustment Disorder with depressed mood
- Adjustment Disorder with mixed depressed mood and anxiety
- Mood disorder (i.e., due to general medical condition, Not Otherwise Specified)
- Depressive Disorder (i.e., Major Depressive Disorder (MDD) single episode, MDD recurrent, Depressive disorder not otherwise specified, Dysthymia)
- In the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in English
Who cannot join
- For Patients in Parts 1- 3:
- In the judgment of the consenting professional and/or as per medical record, severe psychopathology or cognitive impairment likely to interfere with the participation or completion of the protocol or ability to provide meaningful information.
- For Phase 1\&2 only: Score of > 11 on the Blessed Orientation-Memory-Concentration Scale (BOMC)
- For Part 2 only: As per medical record or self report, a diagnosis of a Schizophrenia Spectrum Disorder, current substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, Attenuated Psychotic Disorder, and Adjustment Disorder (except for Adjustment Disorder with Depressed Mood).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to develop an accurate and useful way of measuring older patients' moods and reactions to the combined issue of cancer treatment and aging. Also, the purpose of this study is to test a new self-report measure of depressive symptoms tailored to the needs of older adults with cancer. Findings from this research will help us develop improved methods of diagnosis and treatment.
- Conditions
- Older Cancer Patients
- Being tested
- Patient Interviews, newly developed questionnaire, Pilot Testing the Draft Measure
- Keywords
- Depression, 14-101
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient InterviewsBehavioural
participate in a brief interview
newly developed questionnaireBehavioural
10-16 patients will review draft items and participate in a cognitive interview. 15 older patients will complete the draft measure in order to generate preliminary psychometric data. All interviews will be audio recorded and transcribed by Ubiqus Transcription Company. The audio recordings are uploaded through Ubiqus's secure server and the transcribed audio is returned to the research staff within 48 hours.
Pilot Testing the Draft MeasureBehavioural
The draft measure (approximately 35 items, described above) will be administered to a large sample of older cancer patients (n=150) to generate data to evaluate preliminary psychometric properties (item properties including measures of central tendency, skewness/kurtosis, internal consistency, test/re-test reliability, and construct validity (i.e, convergent and discriminant).and known group differences) to further winnow the measure to include approximately 20 items.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Patients | This protocol aims to design, develop and pilot test a psychometric assessment for depression in older cancer patients. The study is divided in three phases. In Phase 1, approximately 15 depressed patients (as determined clinically) and approximately 15 non-depressed patients will undergo individual interviews. In Phase 2, the team will use the themes and subthemes obtained in Phase 1 to write a set of indicators into questionnaire form. In Phase 3, the newly developed questionnaire will be given to a sample of approximately 150 cancer patients who meet the eligibility criteria. Survey results obtained from this sample of 150 patients will be used to assess internal consistency, conduct item analysis, and determine the unique content of the proposed instrument. Receives: Behavioral: Patient Interviews; Behavioral: newly developed questionnaire; Behavioral: Pilot Testing the Draft Measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
develope psychometric assessment of a self report measure of depression
This protocol aims to design, develop and pilot test a psychometric assessment for depression in older cancer patients.
Measured: 2 years
identify differences in item endorsement between younger and older cancer patients on existing depression measures.
These participants will be asked to complete several existing depression measures.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study start20 Jun 2014
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 329 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fordham University
- Responsible party
- Sponsor
- Investigators
- Rebecca Saracino, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174055
- Sponsor's protocol ID
- 14-101
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2014
- Last updated
- 7 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying and Measuring Depression in Older Cancer Patients
- ClinicalTrials.gov ID
- NCT02174055
- Acronym / sponsor ID
- 14-101
- Conditions
- Older Cancer Patients
- Keywords
- Depression, 14-101
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 329 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Fordham University
- Study start
- 20 Jun 2014 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop an accurate and useful way of measuring older patients' moods and reactions to the combined issue of cancer treatment and aging. Also, the purpose of this study is to test a new self-report measure of depressive symptoms tailored to the needs of older adults with cancer. Findings from this research will help us develop improved methods of diagnosis and treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients | – | Behavioral: Patient Interviews, Behavioral: newly developed questionnaire, Behavioral: Pilot Testing the Draft MeasureThis protocol aims to design, develop and pilot test a psychometric assessment for depression in older cancer patients. The study is divided in three phases. In Phase 1, approximately 15 depressed patients (as determined clinically) and approximately 15 non-depressed patients will undergo individual interviews. In Phase 2, the team will use the themes and subthemes obtained in Phase 1 to write a set of indicators into questionnaire form. In Phase 3, the newly developed questionnaire will be given to a sample of approximately 150 cancer patients who meet the eligibility criteria. Survey results obtained from this sample of 150 patients will be used to assess internal consistency, conduct item analysis, and determine the unique content of the proposed instrument. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- For all Phases, patients who are identified as eligible will be approached in-person in the outpatient clinics or the MSK Counseling Center by members of the research staff, or by letter (physical or electronic).
Key inclusion criteria (11 listed)
- Current or previous cancer diagnosis and treatment (any site and any stage)
- All Phases 1,2,3- 70 years of age or older
- For Phase 1b only; 50 participants ages 50-69 will also be recruited
- For Phase 2 only: As per medical record or self report, history of Depression, Dysthymia, or Adjustment Disorder with Depressed Mood
- For Phase 3 depressive subset: As per medical record or self report, a history of depressive symptoms such as
Key exclusion criteria (4 listed)
- In the judgment of the consenting professional and/or as per medical record, severe psychopathology or cognitive impairment likely to interfere with the participation or completion of the protocol or ability to provide meaningful information.
- For Phase 1\&2 only: Score of > 11 on the Blessed Orientation-Memory-Concentration Scale (BOMC)
- For Part 2 only: As per medical record or self report, a diagnosis of a Schizophrenia Spectrum Disorder, current substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, Attenuated Psychotic Disorder, and Adjustment Disorder (except for Adjustment Disorder with Depressed Mood).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Interviewsparticipate in a brief interview | Behavioural | Cancer Patients |
| newly developed questionnaire10-16 patients will review draft items and participate in a cognitive interview. 15 older patients will complete the draft measure in order to generate preliminary psychometric data. All interviews will be audio recorded and transcribed by Ubiqus Transcription Company. The audio recordings are uploaded through Ubiqus's secure server and the transcribed audio is returned to the research staff within 48 hours. | Behavioural | Cancer Patients |
| Pilot Testing the Draft MeasureThe draft measure (approximately 35 items, described above) will be administered to a large sample of older cancer patients (n=150) to generate data to evaluate preliminary psychometric properties (item properties including measures of central tendency, skewness/kurtosis, internal consistency, test/re-test reliability, and construct validity (i.e, convergent and discriminant).and known group differences) to further winnow the measure to include approximately 20 items. | Behavioural | Cancer Patients |
Primary outcome
develope psychometric assessment of a self report measure of depression
Time frame: 2 years
This protocol aims to design, develop and pilot test a psychometric assessment for depression in older cancer patients.
identify differences in item endorsement between younger and older cancer patients on existing depression measures.
Time frame: 1 year
These participants will be asked to complete several existing depression measures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Saracino, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Older Cancer Patients, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
develope psychometric assessment of a self report measure of depression (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.